Manufacturing Assistant I/II, (Nights, 12hr, 7pm-7am)-2

KBI Biopharma • Durham, NC

2d • Onsite

About The Position

The CMF Manufacturing Assistant position is designed as an introduction to the industry of cGMP manufacturing. This position performs all routine/non-routine cleanings and maintains gowning supplies for the locker rooms and gowning rooms at the CMF GMP facility to support continuous manufacturing operations. This position requires a shift schedule and gowning into a clean room environment. This position requires PPE. Must be able to document, record activities in electronic systems and comply with regulatory requirements, cGMP’s, Policy Documents and SOP’s. Must be able to maintain training at 95% or greater. Must always wear proper PPE and follow all safety guidelines outlined by the SOP and site policies when working in the facility. Must be able to perform general tasks as assigned by supervisor to support manufacturing, i.e staging materials, discarding waste, moving equipment, and other general clean room tasks.

Requirements

• Assistant I: High school diploma or Associate degree with 0+ years of experience. Bio Works Certificate preferred.
• Assistant II: High school diploma or Associate degree with 18+ Months of experience. Bio Works Certificate preferred.
• Ability to read and interpret English documents such as safety rules, standard operating procedures, and procedure manuals.
• Ability to write routine reports and correspondence.
• Ability to communicate with coworkers and supervisor.
• Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form.
• Ability to deal with problems involving several concrete variables in standardized situations.
• Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Must be able to stand, walk, wear steel toe shoes and have the ability to push, pull, squat, lift, reach and carry cleaning supplies and waste as needed, but not to exceed the Essential Physical Functions of the job description.
• Word, Excel, E-mail, ASCTrac and MODA.
• Computer/Tablet, radio, Copy and Fax Machine
• The job requires working 12-hour shifts which may include working overnight
• Due to non-routine cleanings and the manufacturing schedule, it is required, if necessary, to stay past the assigned shift to complete such request.
• This position requires standing for long period of times. For cleaning, this position also requires bending, kneeling, and reaching above head.
• Due to the use of Spor-Klenz, use of PAPR’s or respirators (full faced and half faced respirators) are required for the job description. Facial hair needs to be maintained short enough to ensure a good seal to properly wear the respirator.
• This position is considered “Essential Personnel” which requires 7 days a week work coverage even though the company closes, i.e. inclement weather.
• This position is required to ensure the cleaning is completed every day.

Nice To Haves

• Bio Works Certificate preferred.

Responsibilities

• Performs and Maintains Manufacturing facilities by routine/non-routine cleanings. (Daily, Weekly and Monthly Cleanings)
• Handling and discarding of hazardous and nonhazardous waste.
• Computer: Includes maintaining training and job-related functions.
• Order and stock general supplies in the manufacturing production areas.
• Perform other various task as assigned by the Supervisor/Manager

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED